Medication info
Amlostin Tablet 5mg/10mg

Amlostin Tablet 5mg/10mg

Prescription medicationTablet경구
Ingredient · strength
Atorvastatin Calcium›10.36mg / 1 tabletAmlodipine Besylate›6.94mg / 1 tablet
Manufacturer / importer
(주)킵스바이오파마
Appearance
White oval film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201404571 · Approved 2014.10.02 · Insurance code 693201100

Summary

Main use
(Hypertension, Angina) Improvement of myocardial ischemia and reduction of risk for (cardiovascular diseases)
Who takes it
Adults
Adult dose
This medication is administered only to adults, and the dosage should be individualized for each patient based on the efficacy and tolerability of amlodipine/atorvastatin. Amlodipine (s-Amlodipine) should be administered orally once daily at a dose of 5 (2.5) mg, which can be increased to a maximum of 10 (5) mg per day based on the patient's response. The dosage should be adjusted appropriately depending on symptoms. Atorvastatin can be administered at any time of the day, irrespective of food intake.

Ingredients

Manufacturer
(주)킵스바이오파마

Efficacy & effects

(Hypertension, Angina) Improvement of myocardial ischemia and reduction of risk for (cardiovascular diseases)

  • Hypertension
  • fixed occlusion of coronary arteries
  • vascular spasm of the coronary circulation
  • vasoconstriction
  • myocardial ischemia
  • angina
  • coronary heart disease
  • myocardial infarction
  • stroke
  • revascularization
  • chronic stable angina
  • retinopathy
View approved original text

This medication is used for patients who require the combined administration of two drugs: amlodipine (s-Amlodipine) and atorvastatin. Amlodipine is effective for hypertension, stable angina, and myocardial ischemia caused by vascular spasm and vasoconstriction. It also reduces the risk of hospitalization for angina in patients with recently identified coronary artery disease but without heart failure or reduced cardiac output, as well as the risks associated with coronary revascularization. Atorvastatin reduces the risks of myocardial infarction and stroke in patients at high risk for coronary heart disease and those with type 2 diabetes, and it also lowers the risks of hospitalization for revascularization, angina, and congestive heart failure. Moreover, it effectively lowers LDL cholesterol and triglyceride levels while increasing HDL cholesterol, improving cardiovascular health. Thus, this medication is effectively used for the treatment of cardiovascular diseases and dyslipidemia.

How to take

Adult dose

This medication is administered only to adults, and the dosage should be individualized for each patient based on the efficacy and tolerability of amlodipine/atorvastatin. Amlodipine (s-Amlodipine) should be administered orally once daily at a dose of 5 (2.5) mg, which can be increased to a maximum of 10 (5) mg per day based on the patient's response. The dosage should be adjusted appropriately depending on symptoms. Atorvastatin can be administered at any time of the day, irrespective of food intake.

Precautions

This medication should not be used in certain patients. For instance, patients with allergies to this medication or similar drugs, severe hepatic dysfunction, pregnant or breastfeeding women, and those with muscle disorders should not receive treatment. Additionally, it may pose risks for patients with severe hypotension, heart problems, or in shock. When using this medication, caution is needed for patients with very poor kidney function, elderly patients, alcoholics, and those with a history of liver disease. In particular, if there is a risk of muscle-related disorders, muscle enzyme levels should be tested before treatment and the condition should be closely monitored during treatment. This medication generally has good tolerability, but rarely may cause side effects such as low blood pressure, headache, dizziness, fatigue, indigestion, muscle pain, skin rashes, and others. If severe liver dysfunction or muscle-related symptoms occur, medical personnel should be notified immediately. Pregnant women or women who may become pregnant should use adequate contraception during the course of this medication, and it should be stopped immediately if pregnancy is confirmed. It is also advisable for breastfeeding women to avoid taking this medication. This medication may interact with other drugs, so if the patient is taking other medications, they must inform medical personnel. In particular, the risk of side effects may increase when taken with drugs that affect enzymes responsible for drug metabolism in the liver. In case of overdose, severe hypotension, shock, and heart problems may occur, thus requiring an immediate visit to a medical facility for appropriate treatment. The safety and efficacy of this medication in children or elderly individuals have not been adequately studied, hence caution should be exercised in these age groups. This medication should be kept out of reach of children and care should be taken not to transfer it to other containers, as this may lead to accidents or loss of quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rashes with high fever, blisters, skin peeling, pain in oral/ocular mucosa, severe skin reactions, difficulty breathing or shortness of breath, asthma attacks, respiratory issues with cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and severe headache

Mild side effects

  • Flushing
  • fatigue
  • edema
  • palpitations
  • dizziness
  • headache
  • drowsiness
  • abdominal pain
  • nausea
  • weakness
Show 27 more
  • lethargy
  • pain
  • weight changes
  • hypotension
  • vasculitis
  • muscle tension
  • sensory loss
  • paresthesia
  • peripheral neuropathy
  • syncope
  • dysgeusia
  • tremors
  • extrapyramidal disorder
  • erectile dysfunction
  • gynecomastia
  • changes in bowel habits
  • dry mouth
  • dyspepsia
  • gingival hypertrophy
  • gingival hyperplasia
  • pancreatitis
  • vomiting
  • hyperglycemia
  • arthralgia
  • low back pain
  • muscle cramps
  • myalgia

Not everyone experiences these, and they can vary from person to person.

Storage

This medication must be stored in a tightly sealed container to protect it from air and moisture. Additionally, it should be stored at room temperature between 1°C to 30°C.

Appearance and packaging

Appearance

White oval film-coated tablet

Package unit

30 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.